510(k) K101791
K101791 is an FDA 510(k) premarket notification submitted by Medtech S.A.S for the device "ROSA SURGICAL DEVICE". The FDA issued a decision of Substantially Equivalent on September 23, 2010. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtech S.A.S has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2010
- Date Received
- June 28, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type